| CTRI Number |
CTRI/2022/08/045063 [Registered on: 30/08/2022] Trial Registered Prospectively |
| Last Modified On: |
29/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
STUDY TO SEE THE EFFECT OF SARASWATA CHURNA AND ASHWAGANDHASIDHKSHIR SHIRODHARA IN THE MANAGEMENT OF ATTENTION - DEFICIT HYPERACTIVITY DISORDER (ADHD) IN CHILDREN |
|
Scientific Title of Study
|
CLINICAL STUDY TO EVALUATE THE EFFECT
OF SARASWATA CHURNA AND ASHWAGANDHASIDHKSHIR SHIRODHARA IN THE MANAGEMENT OF ATTENTION - DEFICIT HYPERACTIVITY DISORDER (ADHD) IN CHILDREN-SINGLE ARM OPEN LABELLED TRIAL
|
| Trial Acronym |
Iattention, Hyperactivity, Shirodhara |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MANVITA GIDWANI |
| Designation |
MD Scholar |
| Affiliation |
University Post Graduate Institute of Ayurved Studies Research |
| Address |
PG Department of Kaumarbhritya University Post Graduate Institute of Ayurved Studies Research DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8740981455 |
| Fax |
|
| Email |
manvitagidwani10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish Kumar Singhal |
| Designation |
Assistant Professor |
| Affiliation |
University Post Graduate Institute of Ayurved Studies Research |
| Address |
PG Department of Kaumarbhritya University Post Graduate Institute of Ayurved Studies Research DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636622206 |
| Fax |
|
| Email |
drharish_md@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish Kumar Singhal |
| Designation |
Assistant Professor |
| Affiliation |
University Post Graduate Institute of Ayurved Studies Research |
| Address |
PG Department of Kaumarbhritya University Post Graduate Institute of Ayurved Studies Research DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636622206 |
| Fax |
|
| Email |
drharish_md@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| University Post Graduate Institute of Ayurved Studies Research DSRRAU Jodhpur |
|
|
Primary Sponsor
|
| Name |
University Post Graduate Institute of Ayurved Studies Research DSRRAU Jodhpur |
| Address |
PG Department of Kaumarbhritya University Post Graduate Institute of Ayurved Studies Research DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MANVITA GIDWANI |
University Post Graduate Institute of Ayurved Studies Research DSRRAU Jodhpur |
PG Department of Kaumarbhritya University Post Graduate Institute of Ayurved Studies Research DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
8740981455
manvitagidwani10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F900||Attention-deficit hyperactivity disorder, predominantly inattentive type. Ayurveda Condition: ADHD (MANOVAHA SROTAS VYADHI), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saraswata churna, Reference: Bhaishjya Ratnawali and Bhavprakash Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -madhu and ghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Individual between age group of 6 to 12 years of both sexes having fulfill DSM V criteria. |
|
| ExclusionCriteria |
| Details |
1.Individual below 6 year & above 12 years of age.
2.Mental disorders like conduct disorder, anxiety, depressive disorders, obsessive disorders & compulsive disorder.
3.Children with schizophrenia.
4.Children having medical illness like hearing loss, hypothyroidism, genetic disorder & seizures disorder.
5.Children having congenital deformity or Muscular dystrophy
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE THE CLINICAL EFFICACY OF SARASWATA CHURNA AND ASHWAGANDHASIDHKSHIR SHIRODHARA IN THE MANAGEMENT OF ADHD |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve school performance and health status of children |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="60"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NO |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The effect of saraswata churna and ashwagandhasidhkshir shirodhara in the management of ADHD in children. single arm open labelled trial.my aim is to relief the symptoms of adhd and my sample size is 60 children. duration of study 45 days. age group of 6 to 12 years of both sexes.my follow up every fortnightly and last follow up after 15 days of completion of study.saraswata churna will be in a dose in two divided doses as per young formula. while ashwagandhasidhkshir shirodhara will be given foe 15 days for a duration of 20 minutes daily. |